Policies
On August 28, 2024, the NMPA released the “Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Public Comment).”
For the first time that China NMPA regulation for medical devices has been elevated to law level from regulation since Decree 739, the “Regulations on the Supervision and Administration of Medical Devices.” This shows China intends to increase its medical device development and the quality level.
The major changes that impact foreign companies include those on innovation devices policy, international multi-center clinical trial, clinical trial approvals and the registration renewal time window.
Please click HERE for our comprehensive article
Twenty-Three Medical Devices Proposed to be Exempted from Clinical Trial
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)”, which newly-includes 23 medical devices. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
For the Class III and Class II devices listed in the clinical exempt catalog, please click HERE
New Device Classification Rules Take Effect September 1, 2024
Since September 1, 2024, The NMPA has implemented the new rules for devices classification, stipulated from the “Announcement on Standardizing the Classification of Medical Devices”. It revises the classification processes for devices, combination products and newly developed medical devices, and standardizes the classification materials. For more information please click HERE
Guidelines & Standards
Medical Devices PMS Standard: Aligning Regulatory Framework with Global Requirements
NMPA Center for Medical Device Standardization Administration Issued the draft national standard “Post-Market Surveillance for Medical Device Manufacturers”. It discusses the regulatory framework, responsibilities, and best practices that medical device manufacturers in China must adhere to after their products have been launched into the market.
For our summary of the standard, please click HERE
Featured Article
China’s Regulatory Approach to Software as a Medical Device (SaMD): GMP & Inspection Guidance
To respond to the emerging trend of adopting software in health care, China has told its regulators what to look for when approving software and how evaluating its quality and performance, with a focus on the data and life cycle management.
We provide a comprehensive review on the definition of SaMD in China, SaMD GMP and SaMD onsite inspection, summarizing documents including “Guideline on Medical Device Software”, “Good Manufacturing Practice Annex on Independent Software” and “Good Manufacturing Practice Guideline for Onsite Inspection of Standalone Software”. Visit HERE for the article